Incidence of Ventricular Arrhythmias in Patients With Chronic Total Occlusion Recanalization

NCT03475888 | Completed

• 1 other identifier: NL59827.078.16
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief Summary

A chronic total occlusion (CTO) is common in patients with coronary artery disease. CTO recanalization has been shown to improve survival in comparison to failed CTO recanalization. Whether this is related to ventricular arrhythmias (VA) is unknown. The purpose of this pilot study is to evaluate the incidence of VA after successful CTO recanalization and in those with failed CTO recanalization or untreated CTO. Patients will be monitored using an insertable cardiac monitor.

Conditions

Chronic Total Occlusion of Coronary Artery

Keywords

Chronic Total Occlusion of Coronary Artery; Ventricular Arrythmia; Sustained VT; Ventricular Fibrillation; Implantable loop recorder

Outcome Measures

Primary Outcomes (1)

• Ventricular Arrhythmias

  Sustained ventricular tachycardia (\>30 s) or ventricular fibrillation

  3 years after ICM implantation

Study Arms (2)

Group A

ACTIVE COMPARATOR

Patients who have undergone a successful percutaneous CTO recanalization

Device: Medtronic Reveal LINQ™ Insertable Cardiac Monitor (ICM)

Group B

ACTIVE COMPARATOR

Patients who have undergone a failed percutaneous CTO recanalization or have an untreated CTO

Device: Medtronic Reveal LINQ™ Insertable Cardiac Monitor (ICM)

Interventions

Medtronic Reveal LINQ™ Insertable Cardiac Monitor (ICM) DEVICE

Implantation of Medtronic Reveal LINQ™ ICM

Group A; Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presence of CTO defined as complete obstruction of the vessel with Thrombolysis In Myocardial Infarction (TIMI) flow grade 0 and an estimated duration of ≥3 months, and one of the following:
• A successful percutaneous CTO recanalization for stable angina within the previous 6 months. A successful CTO recanalization is defined as a final TIMI flow grade ≥2 and a residual stenosis ≤30% after stent implantation.
• A failed percutaneous CTO recanalization for stable angina within the previous 6 months. A failed CTO recanalization is defined as not fulfilling the criteria for successful CTO recanalization.
• Untreated CTO diagnosed in the previous 6 months.
• Age ≥18 years.
• Written informed consent.
• Patient agrees to the follow-up including the implantation of the ICM.

You may not qualify if:

• Patients who are potential candidates for an ICD according to the 2015 ESC guidelines.
• Patients who have a cardiac implantable electrical device (CIED) (e.g., pacemaker, ICD).
• Patient has reduced immune function or is otherwise at high risk for infection.
• Patient has had a recent (within 30 days) or otherwise unresolved infection.
• Patient has severe co-morbidity that may cause the patient to be non-compliant with the protocol, confound the data interpretation or is associated with limited life expectancy (i.e., less than one year).

Sponsors & Collaborators

• Erasmus Medical Center: lead
• Medtronic: collaborator

Study Sites (2)

VUMC

Amsterdam, Netherlands

Location

Erasmus Medical Center

Rotterdam, Netherlands

Location

Related Publications (1)

• Assaf A, Sakhi R, Diletti R, Hirsch A, Allaart CP, Bhagwandien R, Firouzi M, Smits PC, Hoogendijk MG, Theuns DAMJ, Yap SC. Incidence of ventricular arrhythmias in patients with chronic total coronary occlusion: Results of the VACTOR study. Int J Cardiol Heart Vasc. 2023 Dec 18;50:101323. doi: 10.1016/j.ijcha.2023.101323. eCollection 2024 Feb.

  PMID: 38188347 RESULT

MeSH Terms

Conditions

Ventricular Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sing-Chien Yap, MD, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Single center pilot study of patients with CTO.

Study Record Dates

• First Submitted: March 12, 2018
• First Posted: March 23, 2018
• Study Start: September 28, 2018
• Primary Completion: December 12, 2022
• Study Completion: December 12, 2022
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2)